The following data is part of a premarket notification filed by The Binding Site Group Ltd. with the FDA for Optilite Rheumatoid Factor Kit.
| Device ID | K162263 |
| 510k Number | K162263 |
| Device Name: | Optilite Rheumatoid Factor Kit |
| Classification | System, Test, Rheumatoid Factor |
| Applicant | THE BINDING SITE GROUP LTD. 8 CALTHORPE ROAD EDGBASTON Birmingham, GB B15 1qt |
| Contact | Jon Lauder |
| Correspondent | Jon Lauder THE BINDING SITE GROUP LTD. 8 CALTHORPE ROAD EDGBASTON Birmingham, GB B15 1qt |
| Product Code | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-11 |
| Decision Date | 2017-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700020015 | K162263 | 000 |